Saturday, July 24, 2010

IBS patients tend to suffer anxiety and depression, but they tire of being told their symptoms of diarrhea, constipation, and/or pain are all in their minds.

Now there's evidence that their underlying problem may be due to the structure of their brains, says Emeran Mayer, MD, professor of medicine, physiology, andpsychiatry at the University of California, Los Angeles.

"Discovering structural changes in the brain ... demonstrates an 'organic' component to IBS and supports the concept of a brain-gut disorder," Mayer says in a news release. "The finding removes the idea once and for all that IBS symptomsare not real and are 'only psychological.' The findings will give us more insight into better understanding IBS."

Mayer, David A. Seminowicz, PhD, and colleagues at UCLA and Canada's McGill University used sophisticated scans to compare the brain anatomy of 55 women with moderate IBS to 48 age-matched healthy women.

The finding: Thinning grey matter -- the part of the brain rich in neurons -- in specific areas of the brain. The affected areas involve:

• Dampening the brain's arousal system. IBS patients tend to be over-sensitive to (and hypervigilant for) bowel sensations. • Controlling emotion. Symptom-related worries and ineffective coping strategies play an important role in chronic pain syndromes. • Controlling pain. Brain thinning in this region was seen only in patients who listed pain as their most bothersome IBS symptom.

Importantly, brain areas linked to anxiety and depression were no different in IBS patients than in anxious or depressed people without IBS.

The findings, Seminowicz and colleagues suggest, point to a difference between IBS and chronic pain syndromes such as fibromyalgia.

In chronic pain syndromes, nerves constantly send increased pain signals to the brain. But in IBS, the brain itself seems to be amplifying pain signals it receives from the bowel.

The researchers say future studies should look at family members of IBS patients, to see if they inherited the same brain anatomy that may increase a person's risk of IBS. If so, the studies may reveal genetic components of IBS and point the way to new treatments.

A department directive, expected to take effect next week, resolves the conflict in veterans facilities between federal law, which outlaws marijuana, and the 14 states that allow medicinal use of the drug, effectively deferring to the states.

The policy will not permit department doctors to prescribe marijuana. But it will address the concern of many patients who use the drug that they could lose access to their prescription pain medication if caught.

Under department rules, veterans can be denied pain medications if they are found to be using illegal drugs. Until now, the department had no written exception for medical marijuana.

This has led many patients to distrust their doctors, veterans say. With doctors and patients pressing the veterans department for formal guidance, agency officials began drafting a policy last fall.

"When states start legalizing marijuana we are put in a bit of a unique position because as a federal agency, we are beholden to federal law," said Dr. Robert Jesse, the principal deputy under secretary for health in the veterans department.

At the same time, Dr. Jesse said, "We didn't want patients who were legally using marijuana to be administratively denied access to pain management programs."

The new, written policy applies only to veterans using medical marijuana in states where it is legal. Doctors may still modify a veteran's treatment plan if the veteran is using marijuana, or decide not to prescribe pain medicine altogether if there is a risk of a drug interaction. But that decision will be made on a case-by-case basis, not as blanket policy, Dr. Jesse said.

Though veterans of the Vietnam War were the first group to use marijuana widely for medical purposes, the population of veterans using it now spans generations, said Michael Krawitz, executive director of Veterans for Medical Marijuana Access, which worked with the department on formulating a policy.

Veterans, some of whom have been at the forefront of the medical marijuana movement, praised the department's decision. They say cannabis helps soothe physical and psychological pain and can alleviate the side effects of some treatments.

"By creating a directive on medical marijuana, the V.A. ensures that throughout its vast hospital network, it will be well understood that legal medical marijuana use will not be the basis for the denial of services," Mr. Krawitz said.

Although the Obama administration has not embraced medical marijuana, last October, in a policy shift, the Justice Department announced that it would not prosecute people who used or distributed it in states where it was legal.

Laura Sweeney, a spokeswoman for the Justice Department, would not comment spefically on the veterans department policy. "What we have said in the past, and what we have said for a while, is that we are going to focus our federal resources on large scale drug traffickers," she said. "We are not going to focus on individual cancer patients or something of the like."

Many clinicians already prescribe pain medication to veterans who use medical marijuana, as there was no rule explicitly prohibiting them from doing so, despite the federal marijuana laws.

Advocates of medical marijuana use say that in the past, the patchwork of veterans hospitals and clinics around the country were sometimes unclear how to deal with veterans who needed pain medications and were legally using medical marijuana. The department's emphasis on keeping patients off illegal drugs and from abusing their medication "gave many practitioners the feeling that they are supposed to police marijuana out of the system," Mr. Krawitz said.

"Many medical-marijuana-using veterans have just abandoned the V.A. hospital system completely for this reason," he said, "and others that stay in the system feel that they are not able to trust that their doctor will be working in their best interests."

In rare cases, veterans have been told that they need to stop using marijuana, even if it is legal, or risk losing their prescription medicine, Mr. Krawitz said.

David Fox, 58, an Army veteran from Pompey's Pillar, Mont., uses medical marijuana legally to help quiet the pain he experiences from neuropathy, a nerve disorder. But he said he was told this year by a doctor at a veterans' clinic in Billings that if he did not stop using marijuana, he would no longer get the pain medication he was also prescribed.

A letter written to Mr. Fox in April from Robin Korogi, the director of the veterans health care system in Montana, explained that the department did not want to prescribe pain medicine in combination with marijuana because there was no evidence that marijuana worked for noncancer patients and because the combination was unsafe.

Wednesday, July 21, 2010

It is established that patients suffering with chronic pain deteriorate while waiting for treatment. The deterioration includes escalating pain and depression and decreased health-related quality of life (Lynch, Campbell et al. 2008). In addition, an international survey of IASP Presidents and other key informants has identified that problems with wait-times for appropriate service or with lack of access to service occur in many nations (Lynch, Campbell et al. 2007).

On October 11, 2004, during the first Global Day Against Pain, IASP joined with the World Health Organization and the European Federation of IASP Chapters in calling for pain control to be recognized as a major public health issue and a human right (Bond and Breivik 2004; Brennan and Cousins 2004). In keeping with the IASP guiding principle that all peoples have a right to treatment of their pain, patients should receive timely access to appropriate care for chronic pain.

To address this problem, it will be necessary to advocate strongly with health care funders and governments who look to health care specialists and the literature for guidance. We believe there are two steps necessary to accomplish this goal:

•Identify appropriate wait-times benchmarks for treatment of chronic pain and produce a document endorsed by IASP.

•Support and pursue multi-national initiatives to address timely and appropriate treatment for the management of chronic pain.

In an effort to begin to address this problem, the IASP President established a Task Force in January 2009 to identify benchmarks to address the first of these two steps.

The Task Force completed an international environmental scan which identified several nations where rigorous initiatives have established guidance or benchmarking documents regarding the issue of wait times for management of chronic pain. These included Australia, Canada, Finland, Norway and the United Kingdom. A summary of the Benchmarks recommended by each of these countries appears in Table 1.

In summary, Finland, Norway and Western Australia (with the rest of Australia likely to follow) lead the world with regard to government mandated guidelines specific for wait-times for treatment of chronic pain. There is significant congruence in the guidelines across nations. The Task Force members have reviewed and synthesized the information and propose the following recommendations.

Recommendation for wait-times:

•Most urgent (1 week): acute painful severe condition with risk of deterioration or chronicity (new CRPS) or pain related to cancer or terminal or end stage illness (acute herpes zoster also requires urgent treatment but ideally should be treated at the primary care level rather than requiring a pain specialist service).

Merck was in trouble. In 2002, the pharmaceutical giant was falling behind its rivals in sales. Even worse, patents on five blockbuster drugs were about to expire, which would allow cheaper generics to flood the market. The company hadn't introduced a truly new product in three years, and its stock price was plummeting.

In interviews with the press, Edward Scolnick, Merck's research director, laid out his battle plan to restore the firm to preeminence. Key to his strategy was expanding the company's reach into the antidepressant market, where Merck had lagged while competitors like Pfizer and GlaxoSmithKline created some of the best-selling drugs in the world. "To remain dominant in the future," he told Forbes, "we need to dominate the central nervous system."

His plan hinged on the success of an experimental antidepressant codenamed MK-869. Still in clinical trials, it looked like every pharma executive's dream: a new kind of medication that exploited brain chemistry in innovative ways to promote feelings of well-being. The drug tested brilliantly early on, with minimal side effects, and Merck touted its game-changing potential at a meeting of 300 securities analysts.

Behind the scenes, however, MK-869 was starting to unravel. True, many test subjects treated with the medication felt their hopelessness and anxiety lift. But so did nearly the same number who took a placebo, a look-alike pill made of milk sugar or another inert substance given to groups of volunteers in clinical trials to gauge how much more effective the real drug is by comparison. The fact that taking a faux drug can powerfully improve some people's health—the so-called placebo effect—has long been considered an embarrassment to the serious practice of pharmacology.

Ultimately, Merck's foray into the antidepressant market failed. In subsequent tests, MK-869 turned out to be no more effective than a placebo. In the jargon of the industry, the trials crossed the futility boundary.

MK-869 wasn't the only highly anticipated medical breakthrough to be undone in recent years by the placebo effect. From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo. Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.

The upshot is fewer new medicines available to ailing patients and more financial woes for the beleaguered pharmaceutical industry. Last November, a new type of gene therapy for Parkinson's disease, championed by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II trials after unexpectedly tanking against placebo. A stem-cell startup called Osiris Therapeutics got a drubbing on Wall Street in March, when it suspended trials of its pill for Crohn's disease, an intestinal ailment, citing an "unusually high" response to placebo. Two days later, Eli Lilly broke off testing of a much-touted new drug for schizophrenia when volunteers showed double the expected level of placebo response.

It's not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late '90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time.

It's not that the old meds are getting weaker, drug developers say. It's as if the placebo effect is somehow getting stronger.

The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis. The stakes could hardly be higher. In today's economy, the fate of a long-established company can hang on the outcome of a handful of tests.

Why are inert pills suddenly overwhelming promising new drugs and established medicines alike? The reasons are only just beginning to be understood. A network of independent researchers is doggedly uncovering the inner workings—and potential therapeutic applications—of the placebo effect. At the same time, drugmakers are realizing they need to fully understand the mechanisms behind it so they can design trials that differentiate more clearly between the beneficial effects of their products and the body's innate ability to heal itself. A special task force of the Foundation for the National Institutes of Health is seeking to stem the crisis by quietly undertaking one of the most ambitious data-sharing efforts in the history of the drug industry. After decades in the jungles of fringe science, the placebo effect has become the elephant in the boardroom.

Frontiers in Headache Medicine and Facial Pain is a specialty section of Frontiers in Neurology. The specialty deals with the basic mechanisms underlying primary and secondary headache as well as facial pain; their diagnosis and management; as well as their psychological and social impact. These are exciting times for headache medicine and facial pain. We are at the threshold of an explosion in the understanding, diagnosis and treatment of migraine and other headaches. New drugs and scientific breakthroughs are transforming the practice of headache medicine: triptans have been developed, and now CGRP antagonist and selective 5-HT1F agonists are being developed. New drugs and procedures are being tested and developed for the preventive treatment of migraine. Concomitant with the development of new treatments is the development of the basic sciences of headache, and the renewed dedication of clinicians to headache treatment and teaching. Neuroimaging allows us to look at the brain in pain. Animal models are created that mimic human migraine. Headache research is vast, increasingly interdisciplinary, rapidly expanding, and intellectually challenging. The mission of Frontiers in Headache Medicine and Facial Pain is to bring all relevant specialties together on a single platform. We welcome submissions in the areas of epidemiology, pathohysiology, genetics, molecular biology, functional and structural neuroimaging, diagnosis, treatment and treatment guidelines, neuropsychology, neuromodulation, and other non-pharmacological therapies. Frontiers in Headache Medicine and Facial Pain will also provide a forum for the publication of papers from psychologists, basic researchers and other professionals involved in the management of headache and facial pain.

Tuesday, July 13, 2010

Emerging Solutions in Pain (ESP) is a nonbranded, educational initiative dedicated to developing tools, information and resources that support improved therapeutic outcomes for chronic pain patients by minimizing the risk of opioid misuse, abuse and addiction. ESP's ever-expanding library of resources includes:

Multimedia programs, clips and features

Accredited activities

Interactive forums

Comprehensive case studies

ESP works with a distinguished panel of clinical experts in pain management and addiction medicine, and with experts in the legal and regulatory issues pertaining to the prescribing of controlled substances, to develop practical, real-world resources that support appropriate risk assessment, patient monitoring, documentation and best practices.

Friday, July 09, 2010

Healthskills is a blog for health providers who want to read about research related to self managing chronic pain.

What you’ll find here over time:

* cognitive behavioural therapy

* chronic pain management

* relaxation

* motivation

* values-based therapy

* research

* psychology

* interdisciplinary teams

* using exposure therapy

I trained as an occupational therapist, and graduated in 1984. Since then I’ve continued study at postgraduate level and my papers have included business skills, ergonomics, mental health therapies, and psychology. I completed by Masters in Psychology in 1999, and started my PhD in 2007.

I have many passions, but one of them is to help people experiencing chronic health problems learn to achieve their potential. I have worked in the field of chronic pain management, helping people develop ‘self management’ skills for 16 years. Many of the skills are directly applicable to people with other health conditions.

This information is written to help people with cancer learn about pain control. Reading this can help you:

• Work with your doctors, nurses, and pharmacists to find the best ways to control your pain• Know about different types of pain and how each type is treated.• Learn about different types of pain medicines.• Know about other ways to help manage pain.• Take your medicines safely.• Talk with your doctors and nurses about your pain and how well your treatment is working.

Having cancer does not always mean having pain. But for people who do have pain, there are many different kinds of medicines, different ways to take the medicines and nondrug methods that can help relieve pain.

Pain can affect all parts of your life. If you have pain, you may not be able to take part in your normal day-to-day activities. You may have trouble sleeping and eating, and be irritable with the people you love. It is easy to get frustrated, sad, and even angry when you are in pain. Family and friends do not always understand how you are feeling, and you may feel very alone in your distress.

You should never accept pain as a normal part of having cancer. All pain can be treated, and most pain can be controlled or relieved. When your pain is controlled, you can sleep and eat better, enjoy being with family and friends, and continue with your work and hobbies.

Thursday, July 08, 2010

Two percent of patients, who received acupuncture for chronic low back pain or neck pain, experienced adverse effects which required either self-treatment (1.2%), medication/physician treatment (0.6%), or hospital admission (0.03%). Using the guidelines of the European Commission, to describe the adverse effects of medicinal products (European Commission: Enterprise and Industry Directorate-General, 2005), these frequencies of adverse effects from acupuncture would be rated as common (self-treatment), uncommon (medication/physician treatment) and rare (hospital admission). The most frequently reported adverse effects from acupuncture were bleeding, hematoma, and pain. Adverse effects persisted for a median of 3days and were associated with higher costs (on average approximately €125 for the 3months period) if treatment was needed. Overall the costs were 9–11% higher in the group which reported adverse effects which needed treatment compared to those without adverse effects. We assume that the number of adverse effects which require treatment influence the overall cost-effectiveness of acupuncture.

We observed additional costs of about €3400 for the 3month period if hospital treatment for pain associated adverse effects was required. When the costs of the adverse effects of the 3month period were hypothetically extrapolated to the whole study population of patients with chronic low back pain and neck pain treated with acupuncture, every patient would have to spend €2.26 to treat the possible adverse effects associated with acupuncture.

This is the first evaluation of the cost and need for treatment due to adverse effects associated with acupuncture. The strengths of this study include the large sample size incorporating more than 700,000 acupuncture treatments, the detailed evaluation within a usual care setting, the high quality cost data provided by the health insurance companies and the direct reporting of adverse events by patients to minimize underreporting bias. However, although patients' reporting tends to be higher than physicians' reporting on adverse effects even their rates can be too low and a underreporting cannot be fully ruled out (Witt et al., 2006).

However, patient reports have limitations such as recall bias, coincidence of acupuncture and undesirable effects. The main limitation is that there was no waiting list group to control for unspecific adverse effects. Also confounding could play a relevant role. Moreover, because of the very large sample included in ASH, categorization of data was necessary. This might have caused information loss to some extent. However, in order to detect rare adverse effects which result in hospital admissions, an observational study is a suitable design.

The number of adverse effects observed in our study appears to be high, but of note is that most of them were mild. Non-steroidal anti-inflammatory drugs also cause adverse effects (serious gastrointestinal effects in 0.1–2.5% of patients per year (Schaffer et al., 2006) or death in 0.04–0.11% of patients (Tramer et al., 2000)). The observation period for acupuncture was only 3months compared to one year for non-steroidal anti-inflammatory drugs, due to this the figures are not directly comparable. Within this study acupuncture treatment was only available once per year which is similar to acupuncture for chronic low back pain within the statutory health insurance system. Based on the results of our study in a large sample we would not have expected very serious adverse effects such as dead to appear more often in a longer treatment period. Overall acupuncture appears to be a safe treatment.

Costs did not differ for patients with and without adverse effects. Higher costs were only observed if patients had adverse effects which required treatment. Overall the parts of the economic analysis are more difficult to interpret. It is difficult to know how to interpret the results that patients who reported inflammation as a side effect and subsequently treated these themselves can have lower costs than those with no adverse effects. However, the number of patients was small and results from economic analysis with a limited number of patients have to be interpreted with caution, because economic data for single patients is highly variable and is sensitive to confounding. Therefore conclusions regarding the attributable costs from adverse effects due to acupuncture in patients admitted to hospital should also be made with caution. Another limitation arises from the fact that our economic analysis is mainly based on data provided by the participating health insurance companies. Any additional payments (particularly co-payments made by patients) were not available and could not be included.

In conclusion adverse effects due to acupuncture can occur. However, most of them are minor and do not require additional treatment. Only when treatment was required did they result in additional expenses.